What does FDA require?
FDA’s guidance on the prescription requirement treats it as the line between compounding and conventional manufacturing. To qualify, the prescription must identify the patient for whom the drug is prescribed, and the compounder distributes only under that prescription.
Do office-use prescriptions count?
No. A prescription that says “for office use” or names a practice instead of a patient does not meet the section 503A requirement, per FDA. Where state law allows them, an outsourcing facility under section 503B can fill these orders. Our 503A vs 503B comparison covers the difference.
What should a prescription record contain?
State law sets the exact list. In practice, expect at least:
- The patient’s name and the details your state requires, such as date of birth or address
- The preparation, strength and directions for use
- Quantity and any refills
- The date written, and an expiry where one applies
- The prescriber’s name, credentials and NPI, plus a signature that meets state rules
Can a prescription be written after an online questionnaire?
It depends on the state. Each state sets its own rules for forming a prescriber-patient relationship, and some require a live video or phone visit for some care. Build your visit flow around the strictest state you plan to serve, and have counsel check it.
How does SourceRX record a prescription?
On a 503A storefront, a prescription is a record written by an identified prescriber for one patient, one preparation, a quantity and an expiry. A compounded order must resolve to that record at checkout. The patient and prescriber details come from the record, so nothing a buyer types can change them, and each fill draws down the quantity. See all the controls.
Sources
General information, not legal or medical advice. Rules vary by state and change over time, so have healthcare counsel review your plans.